Summary: Flavr Savr tomatoes were the first fresh genetically modified
fruit or vegetable sold in the world. It was marketed in the US and
approved for sale in the UK, though never sold here. However, Flavr Savr
was a commercial, and possibly safety, mistake.

Though many of the US Government’s own scientific advisers were
concerned over findings showing possible negative health effects, the US
approved the GM tomato and decided that GM foods in general would not
reqirement pre-market approval in the US. There were other problems:
Calgene made major management mistakes; it was subject to heavy legal
pressure from Monsanto; and the GM tomatoes were even more bland than
conventional fruit. The tomatoes were only ever sold in a small number of
outlets in California and the Mid-West, and then rapidly withdrawn.

At the same time Zeneca had developed a GM tomato for use in puree.
This initially sold well in the UK as it was sold cheaper than non-GM
puree. However, following publicity over safety concerns, the GM puree was
also withdrawn.

1. ‘Conventional’ Tomato Production About seventy million tonnes of
tomatoes were produced worldwide in 1993. Today's global food distribution
system involves food being transported many miles and hours between
producer, processor, retailer and consumer. It is important that ripe
fruit and vegetables do not perish on the journey due to their soft skins.
In the US, the problem is solved in conventional tomato-farming by picking
tomatoes while they are still green and firm, transporting them, and then
spraying them with ethylene (the natural ripening agent) to artificially
ripen and redden them after the journey. 80% of American tomatoes are
managed in this way. However, artificial ripening does not produce the
flavour that the fruit has if left on the vine, and they are usually quite
tasteless.

2. Development of the GM tomato and GM tomato puree Calgene, a small
biotechnology company in California, decided to genetically modify a
tomato that could be picked when ripe and transported without bruising.
The tomato is relatively easy to modify genetically, and it was hoped that
this experience of manipulating tomato ripening could be used for other
fruit. Professor Don Grierson initiated a research group in the
mid-seventies at the University of Nottingham in collaboration with Zeneca
with this in mind.

By late 1991, after ten years of development, Calgene had developed the
Flavr Savr, a ‘delayed-ripening tomato’. They claimed it would have a
longer shelf-life than conventional tomatoes and would provide processors
and consumers with tastier tomatoes because the fruit had been left to
mature on the vine. They had used antisense technology, a method of
gene-silencing which interferes with the production of specific proteins
in the plants. The biotechnology companies were very optimistic in the
early nineties, believing that the supermarkets would soon be widely
selling GM food.

Calgene asked the US Food and Drug Administration (FDA) to approve the
product who unreservedly gave the green light to its widespread growing of
Flavr Savr. In 1993, public concerns about the safety of GM food led to
Calgene asking the FDA to provide a ruling that GM foods are ‘safe’,
particularly with regard to the tomato’s antibiotic resistance genes (Flavr
Savr carries the gene for resistance to the antibiotic kanamycin), which
they provided in mid-1994.

Calgene was only one contender in the race to create the ‘perfect’
tomato. At this same time, soup giants Campbell’s were supporting Zeneca’s
(now AstraZeneca) attempts to produce a GM tomato. The three organisations
were on the verge of legal action against each other when a compromise was
reached in February 1994: Calgene would have the world-wide rights to sell
the fresh-market types of the new tomato, while Zeneca would focus
exclusively on processing tomatoes.

Zeneca developed its first GM product by modifying a tomato to make it
bulkier with reduced water content, therefore increasing viscosity and
making it more suitable for puree or soup. It grew the first of these
crops in California in 1994. In 1996, following FDA approvals, Safeway and
Sainsbury's agreed to sell the world’s first GM tomato puree in the UK:
Zeneca tomatoes made up Safeway Double Concentrated Tomato Puree; Produced
from Genetically Modified Tomato and Sainsbury’s Californian Tomato
Puree; Made with Genetically Modified Tomatoes.

It arrived in the supermarkets in February 1996. The GM puree cost 29p
per 170g while conventional puree cost 29p for 142g. The supermarkets
priced this new GM product very carefully. The reduced processing costs of
the more viscose tomato allowed for a lower shelf price, but the
supermarkets did not want the product to be seen as 'cheap' and therefore
of lower quality. So, it was never sold alongside non-GM tomato paste in
the same size container at a lower price. Instead, it was always sold in
larger containers alongside the smaller containers of non-GM paste, and at
the same price, thus making it look 'better value' but not cheap.
According to Safeway and Sainsbury’s, initial sales were ‘brisk’. By
November 1997, Safeway announced that they had sold 750,000 tins and
average sales per store were greater than those for the conventional
product. By 1999, the GM puree had captured up to 60% of the tinned tomato
market share and was hyped a runaway success.

Several other companies are trying to develop GM tomatoes: Agritope,
Aventis, DNA Plant Technologies, and Seminis. DNA Plant Technologies and
Monsanto sued each other over patent infringements. Before Monsanto
triumphed, DNAP test-marketed a tomato called Endless Summer in New York,
but was then bought by ELM in 1996. However, neither company has marketed
GM tomatoes since. Agritope, gained approval from the FDA in 1996 for a GM
tomato but is not ready to market it. 3. Health Concerns Concerns over the
safety of GM foods from the public and scientists, on top of many business
management errors (see next section), resulted in the eventual failure of
both GM tomato products.

These GMOs were the only GM foods for which the FDA has considered
requiring pre-market approval. Both tomatoes contained marker genes that
gave resistance to the antibiotic kanamycin which is used in medicine.
People were concerned that if the genes passed out of the tomatoes and
entered bacteria, the bacteria could develop resistance to the antibiotic,
undermining its medical effectiveness. The question was referred by
Calgene to the FDA who used Flavr Savr as a GMO test case. They approved
Flavr Savr and Zeneca’s similar product in mid-1994. In doing so they
decided that GM foods in general should not be regulated differently to
non-GM foods and would not require pre-market approval. Unlike food
additives, for which pre-market approval is required in the US, they
argued that GM foods are the same or substantially equivalent to non-GM
foods. However, there was actually no scientific evidence that the
tomatoes were safe for human consumption. In fact, the FDA had ignored
many of its own scientists who were concerned that research had shown that
GM tomatoes had a potential to cause stomach lesions.

Calgene had carried out three 28-day studies. Groups of rats were fed
either a GM tomato, a non-GM tomato, or deionized water. Some of the
studies revealed statistically significant differences between the effects
of the GM and non-GM tomatoes. While one study showed no problems, in the
second gross lesions were observed in four out twenty female rats fed one
of the two lines of transgenic tomato. In the third study gross and
microscopic lesions were found in the rats. These findings, however, was
played down and not publicly communicated by the FDA.

While some scientists blamed the study methodology and argued against
using animal feeding trials to assess GMOs, many FDA scientists questioned
the safety of the tomatoes and the way the FDA management was handling the
approval of GMOs. In a memo dated 16 June 1993 to Linda Kahl, Consumer
Safety Officer at the FDA, Fred Hines, Staff Pathologist at the FDA wrote:
“There is considerable disparity in the reported findings of gastric
erosions or necrosis lesions from the three studies provided by Calgene
Inc. This disparity has not been adequately addressed or explained by the
sponsor or the laboratory where the study was conducted … The criteria
for qualifying a lesion as incidental were not provided in the Sponsor’s
report.”

In an October 1993 memo, the Director of Special Research Skills at the
FDA suggested that the Flavr Savr safety experiments were “hardly strong
evidence that gastric erosions are random and highly variable … the
sponsor (Calgene) admits that no cause for the lesions is established …
the data raise a question of safety”. The Additives Evaluation Branch
added in December 1993 that “the responses Calgene provided were
insufficient to answer the questions that still remain”.

In 1994, Dr Joseph Cummins, Emeritus Professor of Genetics at the
University of West-Ontario warned that the inclusion in Flavr Savr
tomatoes of a genetic sequence from the Cauliflower Mosaic Virus could
create virulent new viruses. In October 1991, Dr Edwin Mathews from the
Department of Health and Human Services and of the FDA's Toxicology Group
wrote to the FDA Biotechnology Working Group saying: “Genetically
modified plants could also contain unexpected high concentrations of plant
toxicants”.

The FDA was obliged to reveal these internal views in 1998 only after a
lawsuit filed by consumer groups, scientists and others (Alliance for
Bio-integrity) in which it was accused of ‘failing to fulfil its
regulatory duties’. Despite the safety concerns, Flavr Savr was also
cleared for sale in the UK but never marketed.

4. Economic Problems Flavr Savr tomatoes were sold under the MacGregor’s
brand name and identified as GM when they arrived in US shops in summer
1994. They sold relatively well at first and were in 2500 stores by June
1995. But this did not last and they were withdrawn less than a year
later. As well as the safety concerns, they cost about twice as much as
non-GM tomatoes, had no better flavour, and were prone to bruising.

Calgene was a small company and accrued large debts while developing
Flavr Savr. As well as legal battles with Monsanto, it made major
mistakes. During the research stage, it used a tomato more suitable for
processing than direct eating which bruised relatively easily - the direct
opposite of its intention. The tomatoes were also bland, instead of being
more tasty. Furthermore, Flavr Savr was developed in California: when
production was moved to Florida, it was profoundly unsuited to the sandy
soil and humidity, and so susceptible to fungal diseases among other
problems. It was already deep in debt when Calgene was then hit by higher
production costs and low world tomato prices. In the end Monsanto finished
off Calgene by claiming ‘patent-infringement’ and buying it out.

Flavr Savr tomatoes were never sold outside California and a few
outlets in the Mid-West. Despite the safety concerns, they were cleared
for sale in the UK but never marketed. In 1996 Safeway said there was ‘no
question of importing Flavr Savr’ to the UK and Sainsbury’s echoed
this by claiming there were ‘not enough benefits to justify stocking
Flavr Savr’. Fresh GM tomatoes have never been sold in the EU.

The last can of AstraZeneca paste was sold in the UK in June 1999. The
product failed because of the safety concerns and economic failure. A
decision to not invest in tube packaging rather than tins, which are used
for tomato puree in the US, has been blamed but the high sales show this
was not an issue. Despite the significant price reduction, overall sales
were only 25% higher than the conventional product which was not enough to
make the product worthwhile. Moreover, the association of tomatoes and GM,
resulted in a slump in sales of all own-label tomato based foods in all
supermarkets, so there were large sales losses. The biotechnology company
made no profit from the product and, like Monsanto, its stock continues to
plunge.